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Squatting on the Toilet and Capsule Endoscopy (SC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340089
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
The Second Affiliated Hospital of Chongqing Medical University

Brief Summary:
This study evaluates the effect of squatting on the toilet on gastric transit time and complete examination rate of capsule endoscopy.In the observation group, the patients could go to squatting on the toilet at any time as they want to after taking the capsule.

Condition or disease Intervention/treatment
Intestinal Diseases Behavioral: squatting on the toilet

Detailed Description:
The subjects were divided into a control group and an observation group according to whether the patient squatted in the toilet, In the control group, the patients took discontinuous right lateral position, walked on a flat road and climbed the stairs alternately. In the observation group, in addition to the above ways, the patients could go to squatting on the toilet at any time in the first hour after taking the capsule. The operator observed the position of capsule every one hour. The examination was over when capsule endoscopy entered the colon. If the capsule remained in the small intestine, the examination continued until the capsule ran out of power.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Squatting on the Toilet on Gastric Transit Time and Complete Examination Rate of Capsule Endoscopy
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
observation group
the patients can go to squatting on the toilet at any time as they want to after taking the capsule
Behavioral: squatting on the toilet
the patients could go to squatting on the toilet at any time as they want to after taking the capsule

control group
The patients can move freely



Primary Outcome Measures :
  1. CER [ Time Frame: 72 hours ]
    complete examination rate


Secondary Outcome Measures :
  1. GTT [ Time Frame: 72 hours ]
    gastric transit time



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
the patients needed to the examination of capsule endoscopy.
Criteria

Inclusion Criteria:

  • unexplained gastrointestinal bleeding, unexplained chronic abdominal pain and diarrhea, suspected Crohn's disease, suspected small intestinal tumor, and patients needing to exclude small intestinal diseases.

Exclusion Criteria:

  • suspected intestinal obstruction and intestinal stenosis, esophageal stenosis or dysphagia, history of abdominal operation, or diabetes mellitus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340089


Locations
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China, Chongqing
The second affiliated hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400010
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Song He, Dr. Director of department
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Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04340089    
Other Study ID Numbers: wuzhixuan2003
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
squatting on the toilet
capsule endoscopy
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases